116TH CONGRESS 2D SESSION H. R. 2339

AN ACT To amend the Federal Food, Drug, and Cosmetic Act with

respect to the sale and marketing of tobacco products,

and for other purposes.

Be it enacted by the Senate and House of Representa-1

tives of the United States of America in Congress assembled, 2

2

•HR 2339 EH

SECTION 1. SHORT TITLE. 1

This Act may be cited as the ‘‘Protecting American 2

Lungs and Reversing the Youth Tobacco Epidemic Act of 3

2020’’. 4

SEC. 2. TABLE OF CONTENTS. 5

The table of contents of this Act is as follows: 6

Sec. 1. Short title.

Sec. 2. Table of contents.

TITLE I—FOOD AND DRUG ADMINISTRATION

Sec. 101. Cigarette graphic health warnings.

Sec. 102. Advertising and sales parity for all deemed tobacco products.

Sec. 103. Reducing child and adolescent nicotine addiction.

Sec. 104. Prohibition against remote retail sales.

Sec. 105. Fees applicable to all tobacco products.

Sec. 106. Regulation of products containing alternative nicotine.

Sec. 107. Update to youth tobacco prevention public awareness campaigns.

Sec. 108. Exemption from premarket review of certain tobacco products.

Sec. 109. Public education.

Sec. 110. Regulations for recordkeeping concerning tracking and tracing.

TITLE II—FEDERAL TRADE COMMISSION

Sec. 201. Advertising of tobacco products.

TITLE III—PUBLIC HEALTH PROGRAMS

Sec. 301. Outreach to medically underserved communities.

Sec. 302. Demonstration grant program to develop strategies for smoking ces-

sation in medically underserved communities.

Sec. 303. Public awareness, education, and prevention campaign.

Sec. 304. Tobacco cessation treatment grants to health centers.

Sec. 305. Grants for research.

TITLE IV—NICOTINE OR VAPING ACCESS PROTECTION AND

ENFORCEMENT

Sec. 401. Increasing civil penalties applicable to certain violations of restric-

tions on sale and distribution of tobacco products.

Sec. 402. Study and report on e-cigarettes.

TITLE V—EXCISE TAX ON NICOTINE USED IN VAPING, ETC.

Sec. 501. Imposition of tax on nicotine for use in vaping, etc.

TITLE VI—FURTHER HEALTH INVESTMENTS

Sec. 601. Waiving Medicare coinsurance for colorectal cancer screening tests.

Sec. 602. Safe harbor for high deductible health plans without deductible for

certain inhalers.

3

•HR 2339 EH

TITLE I—FOOD AND DRUG 1

ADMINISTRATION 2

SEC. 101. CIGARETTE GRAPHIC HEALTH WARNINGS. 3

(a) ISSUANCE DEADLINES.—Not later than March 4

15, 2020, the Secretary of Health and Human Services, 5

acting through the Commissioner of Food and Drugs, 6

shall publish a final rule pursuant to section 4(d) of the 7

Federal Cigarette Labeling and Advertising Act (15 8

U.S.C. 1333(d)). If the Secretary fails to promulgate such 9

final rule by March 15, 2020, then the proposed rule titled 10

‘‘Tobacco Products; Required Warnings for Cigarette 11

Packages and Advertisements’’ published by the Food and 12

Drug Administration on August 16, 2019 (84 Fed. Reg. 13

42754) shall be treated as a final rule beginning on March 14

16, 2020. 15

(b) CONFORMING CHANGE.—The first section 4(d) of 16

the Federal Cigarette Labeling and Advertising Act (15 17

U.S.C. 1333(d)) (relating to graphic labeling statements) 18

is amended by striking ‘‘Not later than 24 months after 19

the date of enactment of the Family Smoking Prevention 20

and Tobacco Control Act, the Secretary’’ and inserting 21

‘‘The Secretary’’. 22

4

•HR 2339 EH

SEC. 102. ADVERTISING AND SALES PARITY FOR ALL 1

DEEMED TOBACCO PRODUCTS. 2

(a) IN GENERAL.—Not later than 1 year after the 3

date of enactment of this Act, the Secretary of Health and 4

Human Services, acting through the Commissioner of 5

Food and Drugs, shall promulgate a final rule amending 6

part 1140 of subchapter K of title 21, Code of Federal 7

Regulations, to apply the provisions of such part 1140 to 8

all tobacco products, as applicable, to which chapter IX 9

of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 10

387a et seq.) applies pursuant to section 901(b) of such 11

Act (21 U.S.C. 387a(b)), as amended by section 103(a) 12

of this Act. 13

(b) EFFECTIVE DATE.—The final rule required by 14

subsection (a) shall take effect on the date that is 2 years 15

after the date of enactment of this Act. 16

SEC. 103. REDUCING CHILD AND ADOLESCENT NICOTINE 17

ADDICTION. 18

(a) APPLICABILITY TO ALL TOBACCO PRODUCTS.— 19

(1) IN GENERAL.—Subsection (b) of section 20

901 of the Federal Food, Drug, and Cosmetic Act 21

(21 U.S.C. 387a) is amended to read as follows: 22

‘‘(b) APPLICABILITY.—This chapter shall apply to all 23

tobacco products.’’. 24

(2) RULE OF CONSTRUCTION.—Paragraph (1) 25

and the amendment made thereby shall not be con-26

5

•HR 2339 EH

strued to limit the applicability of chapter IX of the 1

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 2

387a et seq.) to— 3

(A) products that were listed in section 4

901(b) of such Act as in effect on the day be-5

fore the date of enactment of this Act; and 6

(B) products that were deemed by regula-7

tion to be subject to such chapter pursuant to 8

section 901(b) of such Act as in effect on the 9

day before the date of enactment of this Act. 10

(b) PROHIBITING FLAVORING OF TOBACCO PROD-11

UCTS.— 12

(1) PROHIBITION.— 13

(A) IN GENERAL.—Subparagraph (A) of 14

section 907(a)(1) of the Federal Food, Drug, 15

and Cosmetic Act (21 U.S.C. 387g(a)(1)) is 16

amended to read as follows: 17

‘‘(A) SPECIAL RULES.— 18

‘‘(i) IN GENERAL.—Beginning on the 19

date that is 1 year after the date of enact-20

ment of the Protecting American Lungs 21

and Reversing the Youth Tobacco Epi-22

demic Act of 2020, a tobacco product (in-23

cluding its components, parts, and acces-24

sories, including the tobacco, filter, or 25

6

•HR 2339 EH

paper) that is not an electronic nicotine de-1

livery system shall not contain, as a con-2

stituent (including a smoke constituent) or 3

additive, an artificial or natural flavor 4

(other than tobacco) that is a character-5

izing flavor of the tobacco product or to-6

bacco smoke or an herb or spice, including 7

menthol, mint, mango, strawberry, grape, 8

orange, clove, cinnamon, pineapple, vanilla, 9

coconut, licorice, cocoa, chocolate, cherry, 10

or coffee. 11

‘‘(ii) RULE OF CONSTRUCTION.— 12

Nothing in this subparagraph shall be con-13

strued to limit the Secretary’s authority to 14

take action under this section or other sec-15

tions of this Act applicable to any artificial 16

or natural flavor, herb, or spice. 17

‘‘(iii) APPLICABILITY TO CERTAIN IN-18

DIVIDUALS.—Notwithstanding any provi-19

sion of this Act, no individual who pur-20

chases for individual consumption, pos-21

sesses for individual consumption, or con-22

sumes, a tobacco product that is in viola-23

tion of the prohibition under this subpara-24

graph, including a tobacco product that 25

7

•HR 2339 EH

contains a characterizing flavor of menthol, 1

shall be subject to any criminal penalty 2

under this Act for such purchase, posses-3

sion, or consumption, nor shall such pur-4

chase, possession, or consumption be used 5

as a justification to stop, search, or con-6

duct any other investigative measure 7

against any individual.’’. 8

(B) SAVINGS PROVISION.—Section 9

907(a)(1) of the Federal Food, Drug, and Cos-10

metic Act (21 U.S.C. 387g(a)(1)), as in effect 11

on the date of enactment of this Act, shall re-12

main in effect until the amendment made to 13

such section 907(a)(1) by this paragraph takes 14

effect. 15

(2) FLAVORED ELECTRONIC NICOTINE DELIV-16

ERY SYSTEM.—Section 910 of the Federal Food, 17

Drug, and Cosmetic Act (21 U.S.C. 387j) is amend-18

ed by inserting at the end the following: 19

‘‘(h) FLAVORED ELECTRONIC NICOTINE DELIVERY 20

SYSTEMS.— 21

‘‘(1) RESTRICTION.—Beginning on the date 22

that is 30 days after the date of enactment of the 23

Protecting American Lungs and Reversing the 24

Youth Tobacco Epidemic Act of 2020, any flavored 25

8

•HR 2339 EH

electronic nicotine delivery system that is a new to-1

bacco product, including any solution or other com-2

ponent or part (such as a liquid or its aerosol) shall 3

not contain an artificial or natural flavor (other than 4

tobacco) that is a characterizing flavor, including 5

menthol, mint, mango, strawberry, grape, orange, 6

clove, cinnamon, pineapple, vanilla, coconut, licorice, 7

cocoa, chocolate, cherry, or coffee, unless the Sec-8

retary has issued a marketing order as described in 9

paragraph (2). Nothing in this paragraph shall be 10

construed to limit the Secretary’s authority to take 11

action under this section or other sections of this 12

Act applicable to any artificial or natural flavor, 13

herb, or spice. 14

‘‘(2) REVIEW.—The Secretary shall not issue a 15

marketing order under subsection (c)(1)(A)(i) or a 16

substantial equivalence order under subsection 17

(a)(2)(A)(i) for any electronic nicotine delivery sys-18

tem, including any liquid, solution, or other compo-19

nent or part or its aerosol, that contains an artificial 20

or natural flavor (other than tobacco) that is a char-21

acterizing flavor, unless the Secretary issues an 22

order finding that the manufacturer has dem-23

onstrated that— 24

‘‘(A) use of the characterizing flavor— 25

9

•HR 2339 EH

‘‘(i) will significantly increase the like-1

lihood of smoking cessation among current 2

users of tobacco products; and 3

‘‘(ii) will not increase the likelihood 4

that individuals who do not use tobacco 5

products, including youth, will start using 6

any tobacco product, including an elec-7

tronic nicotine delivery system; and 8

‘‘(B) such electronic nicotine delivery sys-9

tem is not more harmful to users than an elec-10

tronic nicotine delivery system that does not 11

contain any characterizing flavors.’’. 12

(3) DEFINITION OF ELECTRONIC NICOTINE DE-13

LIVERY SYSTEM.—Section 900 of the Federal Food, 14

Drug, and Cosmetic Act (21 U.S.C. 387) is amend-15

ed— 16

(A) by redesignating paragraphs (8) 17

through (22) as paragraphs (9) through (23), 18

respectively; and 19

(B) by inserting after paragraph (7) the 20

following new paragraph: 21

‘‘(8) ELECTRONIC NICOTINE DELIVERY SYS-22

TEM.—The term ‘electronic nicotine delivery system’ 23

means a tobacco product that is an electronic device 24

that delivers nicotine, flavor, or another substance 25

10

•HR 2339 EH

via an aerosolized solution to the user inhaling from 1

the device (including e-cigarettes, e-hookah, e-cigars, 2

vape pens, advanced refillable personal vaporizers, 3

and electronic pipes) and any component, liquid, 4

part, or accessory of such a device, whether or not 5

sold separately.’’. 6

(4) LIMITATION ON ENFORCEMENT.—A law en-7

forcement officer of a State or political subdivision 8

thereof may not enforce (including by making any 9

stop, search, seizure, or arrest or by pursuing any 10

prosecution, trial, or punishment) any provision of 11

section 907(a)(1)(A) or 910(h) of the Federal Food, 12

Drug, and Cosmetic Act, as amended and added by 13

this subsection. 14

SEC. 104. PROHIBITION AGAINST REMOTE RETAIL SALES. 15

(a) IN GENERAL.—Paragraph (4) of section 906(d) 16

of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 17

387f(d)) is amended to read as follows: 18

‘‘(4) PROHIBITION AGAINST REMOTE RETAIL 19

SALES.— 20

‘‘(A) PROHIBITION.—Not later than 18 21

months after the date of enactment of the Pro-22

tecting American Lungs and Reversing the 23

Youth Tobacco Epidemic Act of 2020, the Sec-24

retary shall promulgate a final regulation pro-25

11

•HR 2339 EH

hibiting the retail sale of all tobacco products 1

other than retail sales through a direct, face-to- 2

face exchange between a retailer and a con-3

sumer. 4

‘‘(B) EXCEPTION FOR CERTAIN CIGAR TO-5

BACCO PRODUCTS.— 6

‘‘(i) EXCEPTION.—The regulation re-7

quired by subparagraph (A) shall not apply 8

to tobacco products described in section 9

910(a)(2)(A)(iii). 10

‘‘(ii) APPLICABLE REQUIREMENTS.— 11

Not later than 18 months after the date of 12

enactment of the Protecting American 13

Lungs and Reversing the Youth Tobacco 14

Epidemic Act of 2020, the Secretary shall 15

promulgate regulations regarding the sale 16

and distribution of tobacco products de-17

scribed in section 910(a)(2)(A)(iii) that 18

occur through means other than a direct, 19

face-to-face exchange between a retailer 20

and a consumer in order to prevent the 21

sale and distribution of tobacco products 22

described in section 910(a)(2)(A)(iii) to in-23

dividuals who have not attained the min-24

imum age established by applicable law for 25

12

•HR 2339 EH

the purchase of such products, including 1

requirements for age verification. 2

‘‘(C) RELATION TO OTHER AUTHORITY.— 3

Nothing in this paragraph— 4

‘‘(i) limits the authority of the Sec-5

retary to take additional actions under 6

other provisions of this Act; or 7

‘‘(ii) preempts the authority of a State 8

or local government to establish restric-9

tions on the retail sale of tobacco products 10

that are in addition to, or more stringent 11

than, the prohibition under subparagraph 12

(A).’’. 13

(b) APPLICABILITY.—Section 906(d)(4) of the Fed-14

eral Food, Drug, and Cosmetic Act, as in effect on the 15

day before the date of enactment of this Act, shall con-16

tinue to apply until the effective date of the regulations 17

required by section 906(d)(4) of such Act, as amended by 18

subsection (a). 19

SEC. 105. FEES APPLICABLE TO ALL TOBACCO PRODUCTS. 20

(a) INCREASE IN TOTAL AMOUNT.—Section 21

919(b)(1) of the Federal Food, Drug, and Cosmetic Act 22

(21 U.S.C. 387s(b)(1)) is amended by striking subpara-23

graph (K) and inserting the following subparagraphs: 24

13

•HR 2339 EH

‘‘(K) For fiscal years 2019 and 2020, 1

$712,000,000. 2

‘‘(L) For fiscal year 2021, $812,000,000. 3

‘‘(M) For each subsequent fiscal year, the 4

amount that was applicable for the previous fis-5

cal year, increased by the total percentage 6

change that occurred in the Consumer Price 7

Index for all urban consumers (all items; 8

United States city average) for the 12-month 9

period ending June 30 preceding the fiscal 10

year.’’. 11

(b) APPLICABILITY.— 12

(1) FISCAL YEARS 2020 AND 2021.—Except as 13

amended by subsection (a), for fiscal years 2020 and 14

2021, section 919 of the Federal Food, Drug, and 15

Cosmetic Act (21 U.S.C. 387s) shall apply as in ef-16

fect on the day before the date of enactment of this 17

Act. 18

(2) SUBSEQUENT FISCAL YEARS.—The amend-19

ments made by subsections (c) through (f) apply be-20

ginning with fiscal year 2022. 21

(c) ALLOCATIONS OF ASSESSMENT BY CLASS OF TO-22

BACCO PRODUCTS.—Paragraph (2) of section 919(b) of 23

the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 24

387s(b)) is amended to read as follows: 25

14

•HR 2339 EH

‘‘(2) ALLOCATIONS OF ASSESSMENT BY CLASS 1

OF TOBACCO PRODUCTS.— 2

‘‘(A) IN GENERAL.—The total user fees as-3

sessed and collected under subsection (a) each 4

fiscal year (beginning with fiscal year 2022) 5

with respect to each class of tobacco products 6

to which this chapter applies shall be an 7

amount that is equal to the applicable percent-8

age of each class for the fiscal year multiplied 9

by the amount specified in paragraph (1) for 10

the fiscal year. 11

‘‘(B) APPLICABLE PERCENTAGE.— 12

‘‘(i) IN GENERAL.—For purposes of 13

subparagraph (A), the applicable percent-14

age for a fiscal year for each class of to-15

bacco product shall be the percentage de-16

termined by dividing— 17

‘‘(I) the product of the gross do-18

mestic volume of the class multiplied 19

by the tax rate applicable to the class 20

under section 5701 of the Internal 21

Revenue Code of 1986; and 22

‘‘(II) the sum of the products de-23

termined under subclause (I) for all 24

classes of tobacco products. 25

15

•HR 2339 EH

‘‘(ii) DEFINITION.—For purposes of 1

clause (i), the term ‘gross domestic volume’ 2

means the volume of tobacco products— 3

‘‘(I) removed (as defined by sec-4

tion 5702 of the Internal Revenue 5

Code of 1986); and 6

‘‘(II) not exempt from tax under 7

chapter 52 of the Internal Revenue 8

Code of 1986 at the time of their re-9

moval under that chapter or the Har-10

monized Tariff Schedule of the United 11

States (19 U.S.C. 1202).’’. 12

(d) ALLOCATION OF ASSESSMENT WITHIN EACH 13

CLASS OF TOBACCO PRODUCT.—Section 919(b)(4) of the 14

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 15

387s(b)(4)) is amended by striking ‘‘shall be the percent-16

age determined for purposes of allocations under sub-17

sections (e) through (h) of section 625 of Public Law 108– 18

357’’ and inserting ‘‘shall be allocated on a pro rata basis 19

among the manufacturers and importers of each class of 20

tobacco products to which this chapter applies based on 21

the percentage share of each manufacturer’s or importer’s 22

share of gross domestic volume within such class on a 23

quarterly basis, based on data for the second preceding 24

quarter’’. 25

16

•HR 2339 EH

(e) OTHER AMENDMENTS.—Section 919(b) of the 1

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 2

387s(b)) is amended— 3

(1) by striking paragraph (5); 4

(2) by redesignating paragraphs (6) and (7) as 5

paragraphs (5) and (6), respectively; and 6

(3) by amending paragraph (6), as redesig-7

nated, to read as follows: 8

‘‘(6) MEMORANDUM OF UNDERSTANDING; RE-9

PORTING.— 10

‘‘(A) TRANSFER OF INFORMATION.—The 11

Secretary shall request the appropriate Federal 12

agency to enter into a memorandum of under-13

standing that provides for the regular and time-14

ly transfer from the head of such agency to the 15

Secretary of all necessary information regarding 16

all tobacco product manufacturers and import-17

ers required to pay user fees. The Secretary 18

shall maintain all disclosure restrictions estab-19

lished by the head of such agency regarding the 20

information provided under the memorandum of 21

understanding. 22

‘‘(B) REPORTING.— 23

‘‘(i) MANUFACTURER REPORTING.— 24

The Secretary may require the manufac-25

17

•HR 2339 EH

turers and importers of each class of to-1

bacco products to which this chapter ap-2

plies to submit such information, by such 3

time, and in such manner, as the Secretary 4

determines to be necessary to implement 5

this section. 6

‘‘(ii) REPORTS TO CONGRESS.—For 7

fiscal year 2020 and each subsequent fiscal 8

year for which fees are collected under this 9

section, the Secretary shall, not later than 10

120 days after the end of the respective 11

fiscal year, submit to the Congress finan-12

cial and performance reports with respect 13

to such fees.’’. 14

(f) PROHIBITED ACT.—Section 301(q)(1)(B) of the 15

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 16

331(q)(1)(B)) is amended by inserting ‘‘919(b)(6)(B),’’ 17

before ‘‘or 920’’. 18

SEC. 106. REGULATION OF PRODUCTS CONTAINING ALTER-19

NATIVE NICOTINE. 20

(a) IN GENERAL.—The Secretary of Health and 21

Human Services, acting through the Commissioner of 22

Food and Drugs, shall— 23

(1) not later than 1 year after the date of en-24

actment of this Act, issue an interim final rule pro-25

18

•HR 2339 EH

viding for the regulation of products containing al-1

ternative nicotine under the Federal Food, Drug, 2

and Cosmetic Act (21 U.S.C. 301 et seq.); and 3

(2) not later than 2 years after such date of en-4

actment, issue a final rule providing for such regula-5

tion. 6

(b) ALTERNATIVE NICOTINE.—In this section, the 7

term ‘‘alternative nicotine’’ means nicotine that is not 8

made or derived from tobacco plants and may include nic-9

otine that is chemically synthesized, synthesized from re-10

combinant genetic technology, or extracted from non-to-11

bacco plants. 12

SEC. 107. UPDATE TO YOUTH TOBACCO PREVENTION PUB-13

LIC AWARENESS CAMPAIGNS. 14

(a) IN GENERAL.—The Secretary of Health and 15

Human Services shall— 16

(1) review all public health awareness cam-17

paigns of the Department of Health and Human 18

Services designed to educate at-risk individuals 19

about the harmful effects of tobacco use, including 20

the use of e-cigarettes and other electronic nicotine 21

delivery systems; and 22

(2) as applicable, modify such campaigns to in-23

clude awareness and education materials designed 24

for individuals who are 18 to 21 years of age. 25

19

•HR 2339 EH

(b) CONSULTATION.—In carrying out subsection (a), 1

the Secretary of Health and Human Services may consult 2

with medical and public health associations and nonprofit 3

organizations. 4

SEC. 108. EXEMPTION FROM PREMARKET REVIEW OF CER-5

TAIN TOBACCO PRODUCTS. 6

(a) IN GENERAL.—Section 910(a)(2) of the Federal 7

Food, Drug, and Cosmetic Act (21 U.S.C. 387j(a)(2)) is 8

amended— 9

(1) in subparagraph (A)— 10

(A) in clause (i)(II), by striking ‘‘or’’; 11

(B) in clause (ii), by striking the period at 12

the end and inserting ‘‘; or’’; and 13

(C) by adding at the end the following: 14

‘‘(iii) subject to subparagraph (C), for 15

the period beginning on the date of the en-16

actment of the Protecting American Lungs 17

and Reversing the Youth Tobacco Epi-18

demic Act of 2020 and ending on Sep-19

tember 30, 2028, the tobacco product is a 20

cigar and— 21

‘‘(I) is wrapped in whole tobacco 22

leaf; 23

‘‘(II) contains a 100-percent leaf 24

tobacco binder; 25

20

•HR 2339 EH

‘‘(III) contains primarily long 1

filler tobacco; 2

‘‘(IV) does not have a character-3

izing flavor other than tobacco; 4

‘‘(V) weighs more than 6 pounds 5

per 1000 units; 6

‘‘(VI) has no filter, tip, or non- 7

tobacco mouthpiece; 8

‘‘(VII)(aa) is made by combining 9

manually the wrapper, filler, and 10

binder and is capped by hand; or 11

‘‘(bb) has a homogenized tobacco 12

leaf binder and is made in the United 13

States using human hands to lay the 14

100-percent leaf tobacco binder onto 15

only one machine that bunches, 16

wraps, and caps each individual cigar; 17

and 18

‘‘(VIII) has a retail price (after 19

discounts or coupons) per cigar of no 20

less than— 21

‘‘(aa) for calendar years 22

2019 and 2020, $12; and 23

‘‘(bb) for each subsequent 24

calendar year, $12 multiplied by 25

21

•HR 2339 EH

any percent increase in the Con-1

sumer Price Index for all urban 2

consumers (all items; U.S. city 3

average) since calendar year 4

2020.’’; and 5

(2) by adding at the end the following: 6

‘‘(C) DETERMINATION OF APPLICA-7

BILITY.— 8

‘‘(i) IN GENERAL.—The Secretary 9

shall, notwithstanding subparagraph 10

(A)(iii) or any determination of substantial 11

equivalence, if any of the conditions speci-12

fied in clause (ii) are met— 13

‘‘(I) withdraw any exemption ap-14

plicable to a tobacco product or prod-15

ucts described in such subparagraph; 16

‘‘(II) require that applications for 17

review under this section be submitted 18

with respect to such product or prod-19

ucts; and 20

‘‘(III) require that manufacturers 21

may only market such tobacco product 22

after the issuance of an order under 23

subsection (c)(1)(A)(i) with respect to 24

such product or products. 25

22

•HR 2339 EH

‘‘(ii) CONDITIONS.—The conditions 1

specified in this clause are that— 2

‘‘(I) the Secretary determines 3

that the use of a tobacco product or 4

products described in subparagraph 5

(A)(iii) has resulted in an emerging 6

public health threat; 7

‘‘(II) data from a National Youth 8

Tobacco Survey (or successor survey) 9

conducted after the date of the enact-10

ment of the Protecting American 11

Lungs and Reversing the Youth To-12

bacco Epidemic Act of 2020 identifies 13

a rise in youth usage of tobacco prod-14

ucts described in section 15

910(a)(2)(A)(iii); or 16

‘‘(III) the Secretary determines 17

that a tobacco product or products no 18

longer meets the criteria specified in 19

such subparagraph.’’. 20

(b) NATIONAL ACADEMIES STUDY AND REPORT.— 21

(1) IN GENERAL.—The Secretary of Health and 22

Human Services, acting through the Commissioner 23

of Food and Drugs, shall enter into an agreement 24

with the National Academies of Sciences, Engineer-25

23

•HR 2339 EH

ing, and Medicine under which the National Acad-1

emies shall conduct a study on— 2

(A) the public health impact of having to-3

bacco products described in subsection 4

(a)(2)(A)(iii) of section 910 of the Federal 5

Food, Drug, and Cosmetic Act (21 U.S.C. 6

387j), as amended by subsection (a), exempt 7

from premarket review under such section; 8

(B) the youth usage of such tobacco prod-9

ucts; and 10

(C) the market share of such products. 11

(2) REPORT.—The agreement under paragraph 12

(1) shall include a requirement that the National 13

Academies of Sciences, Engineering, and Medicine 14

submit to Congress, not later than December 31, 15

2026, a report on the findings of the study con-16

ducted under such paragraph. 17

SEC. 109. PUBLIC EDUCATION. 18

Section 906 of the Federal Food, Drug, and Cosmetic 19

Act (21 U.S.C. 387f) is amended by adding at the end 20

the following: 21

‘‘(g) EDUCATION ON TOBACCO PRODUCTS.— 22

‘‘(1) IN GENERAL.—Beginning not later than 6 23

months after the date of the enactment of the Pro-24

tecting American Lungs and Reversing the Youth 25

24

•HR 2339 EH

Tobacco Epidemic Act of 2020, the Secretary of 1

Health and Human Services, acting through the 2

Commissioner of Food and Drugs and in consulta-3

tion with the Surgeon General of the Public Health 4

Service, shall provide educational materials for 5

health care providers, members of the public, and 6

law enforcement officials, regarding— 7

‘‘(A) the authority of the Food and Drug 8

Administration with respect to the regulation of 9

tobacco products (including enforcement of such 10

regulation); 11

‘‘(B) the general processes of the Food and 12

Drug Administration for enforcing restrictions 13

on the manufacture and sale of tobacco prod-14

ucts; 15

‘‘(C) the general enforcement actions the 16

Food and Drug Administration may take to im-17

plement the prohibition on characterizing fla-18

vors in tobacco products under section 19

907(a)(1); 20

‘‘(D) the public health impact of tobacco 21

products with characterizing flavors; and 22

‘‘(E) other information as the Secretary 23

determines appropriate. 24

25

•HR 2339 EH

‘‘(2) CONTENT.—Educational materials pro-1

vided under paragraph (1) may include— 2

‘‘(A) explanations of key statutory and 3

regulatory terms, including the terms ‘tobacco 4

product’, ‘component parts’, ‘accessories’, ‘con-5

stituent’, ‘additive’, ‘tobacco product manufac-6

turer’, and ‘characterizing flavor’; 7

‘‘(B) an explanation of the Food and Drug 8

Administration’s jurisdiction to regulate tobacco 9

products, including tobacco products with char-10

acterizing flavors under section 907(a)(1); 11

‘‘(C) general educational information re-12

lated to enforcement tools and processes used 13

by the Food and Drug Administration for viola-14

tions of the prohibition specified in section 15

907(a)(1); 16

‘‘(D) information on the health effects of 17

using tobacco products, including those with the 18

characterizing flavors referred to in section 19

907(a)(1); and 20

‘‘(E) information on resources available re-21

lated to smoking cessation. 22

‘‘(3) FORMAT.—Educational materials provided 23

under paragraph (1) may be— 24

26

•HR 2339 EH

‘‘(A) published in any format, including an 1

internet website, video, fact sheet, infographic, 2

webinar, or other format, as the Secretary de-3

termines is appropriate and applicable; and 4

‘‘(B) tailored for the unique needs of 5

health care providers, members of the public, 6

law enforcement officers, and other audiences, 7

as the Secretary determines appropriate. 8

‘‘(4) FUNDING.—To carry out this subsection, 9

there is authorized to be appropriated, and there is 10

appropriated, out of any funds in the Treasury not 11

otherwise appropriated, $5,000,000 for each of fiscal 12

years 2021 through 2025. Funds made available by 13

the preceding sentence to carry out this subsection 14

shall be in addition to funds that are derived from 15

fees under section 919 and are otherwise made avail-16

able to carry out this chapter.’’. 17

SEC. 110. REGULATIONS FOR RECORDKEEPING CON-18

CERNING TRACKING AND TRACING. 19

The Secretary of Health and Human Services, acting 20

through the Commissioner of Food and Drugs, shall pro-21

mulgate the regulations required by section 920(b) of the 22

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387t) 23

in accordance with the following schedule: 24

27

•HR 2339 EH

(1) Not later than 1 year after the date of en-1

actment of this Act, the Secretary shall issue pro-2

posed regulations. 3

(2) Not later than 2 years after the date of en-4

actment of this Act, the Secretary shall promulgate 5

final regulations. 6

TITLE II—FEDERAL TRADE 7

COMMISSION 8

SEC. 201. ADVERTISING OF TOBACCO PRODUCTS. 9

(a) ADVERTISING OF ELECTRONIC NICOTINE DELIV-10

ERY SYSTEMS.— 11

(1) IN GENERAL.—It shall be unlawful— 12

(A) to market, advertise, or promote any 13

electronic nicotine delivery system in a manner 14

that appeals to an individual under 21 years of 15

age; or 16

(B) to market, advertise, promote, or en-17

dorse, or to compensate any person for the 18

marketing, advertising, promotion, or endorse-19

ment of, any electronic nicotine delivery system 20

without clearly disclosing that the communica-21

tion is an advertisement, unless the communica-22

tion is unambiguously identifiable as an adver-23

tisement. 24

(2) ENFORCEMENT BY COMMISSION.— 25

28

•HR 2339 EH

(A) UNFAIR OR DECEPTIVE ACTS OR PRAC-1

TICES.—A violation of paragraph (1) shall be 2

treated as a violation of a regulation under sec-3

tion 18(a)(1)(B) of the Federal Trade Commis-4

sion Act (15 U.S.C. 57a(a)(1)(B)) regarding 5

unfair or deceptive acts or practices. 6

(B) POWERS OF COMMISSION.—The Com-7

mission shall enforce paragraph (1) in the same 8

manner, by the same means, and with the same 9

jurisdiction, powers, and duties as though all 10

applicable terms and provisions of the Federal 11

Trade Commission Act (15 U.S.C. 41 et seq.) 12

were incorporated into and made a part of this 13

Act. Any person who violates such paragraph 14

shall be subject to the penalties and entitled to 15

the privileges and immunities provided in the 16

Federal Trade Commission Act. 17

(3) ENFORCEMENT BY STATE ATTORNEYS GEN-18

ERAL.— 19

(A) IN GENERAL.—If the attorney general 20

of a State has reason to believe a violation of 21

paragraph (1) has occurred or is occurring, the 22

attorney general, in addition to any authority 23

the attorney general may have to bring an ac-24

tion in State court under the law of the State, 25

29

•HR 2339 EH

may bring a civil action in any court of com-1

petent jurisdiction to— 2

(i) enjoin further such violation by the 3

defendant; 4

(ii) enforce compliance with such 5

paragraph; 6

(iii) obtain civil penalties in the same 7

amount as may be obtained by the Com-8

mission in a civil action under section 5(m) 9

of the Federal Trade Commission Act (15 10

U.S.C. 45(m)); or 11

(iv) obtain damages, restitution, or 12

other compensation on behalf of residents 13

of the State. 14

(B) NOTICE.—Before filing an action 15

under subparagraph (A), the attorney general 16

of a State shall provide to the Commission a 17

written notice of such action and a copy of the 18

complaint for such action. If the attorney gen-19

eral determines that it is not feasible to provide 20

the notice described in this subparagraph before 21

the filing of the action, the attorney general 22

shall provide written notice of the action and a 23

copy of the complaint to the Commission imme-24

diately upon the filing of the action. 25

30

•HR 2339 EH

(C) AUTHORITY OF FEDERAL TRADE COM-1

MISSION.— 2

(i) IN GENERAL.—On receiving notice 3

under subparagraph (B) of an action 4

under subparagraph (A), the Commission 5

shall have the right— 6

(I) to intervene in the action; 7

(II) upon so intervening, to be 8

heard on all matters arising therein; 9

and 10

(III) to file petitions for appeal. 11

(ii) LIMITATION ON STATE ACTION 12

WHILE FEDERAL ACTION IS PENDING.—If 13

the Commission has instituted a civil ac-14

tion for violation of paragraph (1) (re-15

ferred to in this clause as the ‘‘Federal ac-16

tion’’), no attorney general of a State may 17

bring an action under subparagraph (A) 18

during the pendency of the Federal action 19

against any defendant named in the com-20

plaint in the Federal action for any viola-21

tion of such paragraph alleged in such 22

complaint. 23

(D) RELATIONSHIP WITH STATE-LAW 24

CLAIMS.— 25

31

•HR 2339 EH

(i) PRESERVATION OF STATE-LAW 1

CLAIMS.—Nothing in this section shall pre-2

vent the attorney general of a State from 3

bringing an action under State law for acts 4

or practices that also violate paragraph 5

(1). 6

(ii) ASSERTION IN SAME CIVIL AC-7

TION.—If the attorney general of a State 8

has authority to bring an action under 9

State law for acts or practices that also 10

violate paragraph (1), the attorney general 11

may assert the State-law claim and the 12

claim for violation of such paragraph in 13

the same civil action. 14

(E) ACTIONS BY OTHER STATE OFFI-15

CIALS.—In addition to civil actions brought by 16

attorneys general under subparagraph (A), any 17

other consumer protection officer of a State 18

who is authorized by the State to do so may 19

bring a civil action under such subparagraph, 20

subject to the same requirements and limita-21

tions that apply under this paragraph to civil 22

actions brought by attorneys general. 23

(4) RULEMAKING AUTHORITY.—The Commis-24

sion may promulgate regulations under section 553 25

32

•HR 2339 EH

of title 5, United States Code, to implement para-1

graph (1). 2

(b) REPORT TO CONGRESS ON TOBACCO PRODUCT 3

ADVERTISING.— 4

(1) IN GENERAL.—Not later than 2 years after 5

the date of the enactment of this Act, and annually 6

thereafter, the Commission shall submit to Congress 7

a report relating to each category of products de-8

scribed in paragraph (2) (or a single report a por-9

tion of which relates to each such category) that 10

contains the following: 11

(A) Information on domestic sales and ad-12

vertising and promotional activity by the manu-13

facturers that have the largest market shares of 14

the product category. 15

(B) Such recommendations for legislation 16

as the Commission may consider appropriate. 17

(2) PRODUCT CATEGORIES DESCRIBED.—The 18

categories of products described in this paragraph 19

are the following: 20

(A) Cigarettes. 21

(B) Cigars. 22

(C) Smokeless tobacco. 23

(D) Electronic nicotine delivery systems. 24

33

•HR 2339 EH

(c) PRESERVATION OF AUTHORITY.—Nothing in this 1

section may be construed in any way to limit the Commis-2

sion’s authority under any other provision of law. 3

(d) DEFINITIONS.—In this section: 4

(1) CIGAR.—The term ‘‘cigar’’ means a tobacco 5

product that— 6

(A) is not a cigarette; and 7

(B) is a roll of tobacco wrapped in leaf to-8

bacco or any substance containing tobacco. 9

(2) CIGARETTE.—The term ‘‘cigarette’’ has the 10

meaning given such term in section 900 of the Fed-11

eral Food, Drug, and Cosmetic Act (21 U.S.C. 387). 12

(3) COMMISSION.—The term ‘‘Commission’’ 13

means the Federal Trade Commission. 14

(4) ELECTRONIC NICOTINE DELIVERY SYS-15

TEM.—The term ‘‘electronic nicotine delivery sys-16

tem’’ means a tobacco product that is an electronic 17

device that delivers nicotine, flavor, or another sub-18

stance via an aerosolized solution to the user inhal-19

ing from the device (including e-cigarettes, e-hookah, 20

e-cigars, vape pens, advanced refillable personal va-21

porizers, and electronic pipes) and any component, 22

liquid, part, or accessory of such a device, whether 23

or not sold separately. 24

34

•HR 2339 EH

(5) ENDORSE.—The term ‘‘endorse’’ means to 1

communicate an advertising message (including a 2

verbal statement, demonstration, or depiction of the 3

name, signature, likeness, or other identifying per-4

sonal characteristics of an individual or the name or 5

seal of an organization) that consumers are likely to 6

believe reflects the opinions, beliefs, findings, or ex-7

periences of a party other than the sponsoring ad-8

vertiser, even if the views expressed by such party 9

are identical to those of the sponsoring advertiser. 10

(6) NICOTINE.—The term ‘‘nicotine’’ has the 11

meaning given such term in section 900 of the Fed-12

eral Food, Drug, and Cosmetic Act (21 U.S.C. 387). 13

(7) SMOKELESS TOBACCO.—The term ‘‘smoke-14

less tobacco’’ has the meaning given such term in 15

section 900 of the Federal Food, Drug, and Cos-16

metic Act (21 U.S.C. 387). 17

(8) TOBACCO PRODUCT.—The term ‘‘tobacco 18

product’’ has the meaning given such term in section 19

201 of the Federal Food, Drug, and Cosmetic Act 20

(21 U.S.C. 321). 21

35

•HR 2339 EH

TITLE III—PUBLIC HEALTH 1

PROGRAMS 2

SEC. 301. OUTREACH TO MEDICALLY UNDERSERVED COM-3

MUNITIES. 4

Section 399V of the Public Health Service Act (42 5

U.S.C. 280g–11) is amended— 6

(1) in subsection (b)— 7

(A) by redesignating paragraphs (4) and 8

(5) as paragraphs (5) and (6), respectively; and 9

(B) by inserting after paragraph (3) the 10

following: 11

‘‘(4) to educate and provide guidance to medi-12

cally underserved communities, particularly racial 13

and ethnic minority populations, regarding effective 14

evidence-based strategies— 15

‘‘(A) to prevent tobacco, e-cigarette, and 16

nicotine addiction, including among youth; and 17

‘‘(B) for smoking cessation, including ces-18

sation of the use of menthol-flavored tobacco 19

products, and the cessation of the use of e-ciga-20

rettes and electronic nicotine delivery systems;’’; 21

(2) in subsection (d)(1)(B), by inserting ‘‘, in-22

cluding chronic diseases related to and caused by to-23

bacco use’’ after ‘‘diseases’’; and 24

36

•HR 2339 EH

(3) in subsection (j), by striking ‘‘are author-1

ized to be appropriated, such sums as may be nec-2

essary to carry out this section for each of fiscal 3

years 2010 through 2014’’ and inserting ‘‘is author-4

ized to be appropriated, and there is appropriated, 5

out of any funds in the Treasury not otherwise ap-6

propriated, $75,000,000 to carry out this section for 7

each of fiscal years 2021 through 2025’’. 8

SEC. 302. DEMONSTRATION GRANT PROGRAM TO DEVELOP 9

STRATEGIES FOR SMOKING CESSATION IN 10

MEDICALLY UNDERSERVED COMMUNITIES. 11

Part B of title III of the Public Health Service Act 12

(42 U.S.C. 243 et seq.) is amended by inserting after sec-13

tion 317U (42 U.S.C. 247b–23) the following: 14

‘‘SEC. 317V. DEMONSTRATION GRANT PROGRAM TO DE-15

VELOP STRATEGIES FOR SMOKING CES-16

SATION IN MEDICALLY UNDERSERVED COM-17

MUNITIES. 18

‘‘(a) IN GENERAL.—The Secretary, acting through 19

the Director of the Centers for Disease Control and Pre-20

vention, shall establish a demonstration program to award 21

grants to, or contract with, State, local, or Tribal public 22

health departments to support— 23

‘‘(1) the development of improved evidence- 24

based strategies for smoking cessation, including 25

37

•HR 2339 EH

cessation of the use of menthol-flavored tobacco 1

products, and the cessation of the use of e-cigarettes 2

and electronic nicotine delivery systems, for popu-3

lations in medically underserved communities, par-4

ticularly racial and ethnic minority populations; 5

‘‘(2) the development of improved communica-6

tion and outreach tools to reach populations in medi-7

cally underserved communities, particularly racial 8

and ethnic minority populations, addicted to tobacco 9

products, including e-cigarettes and menthol-flavored 10

tobacco products; and 11

‘‘(3) improved coordination, access, and refer-12

rals to services for tobacco cessation and the ces-13

sation of the use of e-cigarettes and electronic nico-14

tine delivery systems, including tobacco cessation 15

products approved by the Food and Drug Adminis-16

tration and mental health and counseling services. 17

‘‘(b) APPLICATION.—To be eligible to receive a grant 18

under subsection (a), a State, local, or Tribal public health 19

department shall submit to the Secretary an application 20

at such time, in such manner, and containing such infor-21

mation as the Secretary may require. 22

‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—To 23

carry out this section, there is authorized to be appro-24

priated, and there is appropriated, out of any funds in 25

38

•HR 2339 EH

the Treasury not otherwise appropriated, $75,000,000 for 1

each of fiscal years 2021 through 2025.’’. 2

SEC. 303. PUBLIC AWARENESS, EDUCATION, AND PREVEN-3

TION CAMPAIGN. 4

Part B of title III of the Public Health Service Act 5

(42 U.S.C. 243 et seq.), as amended by section 302, is 6

further amended by inserting after section 317V the fol-7

lowing new section: 8

‘‘SEC. 317W. PUBLIC AWARENESS, EDUCATION, AND PRE-9

VENTION CAMPAIGN REGARDING TOBACCO. 10

‘‘(a) IN GENERAL.—The Secretary, acting through 11

the Director of the Centers for Disease Control and Pre-12

vention and in consultation with the Surgeon General of 13

the Public Health Service, shall develop and implement a 14

national campaign to educate youth and young adults, 15

parents, clinicians, health professionals, and others about 16

the harms associated with the use by youth and young 17

adults of tobacco products, including e-cigarettes. 18

‘‘(b) REQUIREMENTS.—The campaign under this sec-19

tion shall— 20

‘‘(1) be an evidence-based media and public en-21

gagement initiative; 22

‘‘(2) be carried out through competitively bid 23

contracts; 24

39

•HR 2339 EH

‘‘(3) include the development of culturally and 1

linguistically competent resources that may be tai-2

lored for communities with high rates of youth to-3

bacco use; 4

‘‘(4) be complementary to, and coordinated 5

with, any other Federal efforts; and 6

‘‘(5) include message testing to identify cul-7

turally and linguistically competent and effective 8

messages for behavioral change. 9

‘‘(c) OPTIONAL COMPONENTS.—The campaign under 10

this section may include— 11

‘‘(1) the use of— 12

‘‘(A) television, radio, print, the internet, 13

and other commercial marketing venues; and 14

‘‘(B) in-person public communications; and 15

‘‘(2) the award of grants to State, local, and 16

Tribal public health departments to encourage part-17

nerships with community organizations and health 18

care providers to develop and deliver evidence-based 19

strategies to prevent youth tobacco use. 20

‘‘(d) FUNDING.—To carry out this section, there is 21

authorized to be appropriated, and there is appropriated, 22

out of any funds in the Treasury not otherwise appro-23

priated, $45,000,000 for each of fiscal years 2021 through 24

2025.’’. 25

40

•HR 2339 EH

SEC. 304. TOBACCO CESSATION TREATMENT GRANTS TO 1

HEALTH CENTERS. 2

(a) IN GENERAL.—Section 330 of the Public Health 3

Service Act (42 U.S.C. 254b) is amended— 4

(1) by redesignating subsections (k) through (r) 5

as subsections (l) through (s), respectively; and 6

(2) by adding after subsection (j) the following 7

new subsection: 8

‘‘(k) TOBACCO CESSATION GRANTS.— 9

‘‘(1) IN GENERAL.—The Secretary may award 10

grants to health centers to provide comprehensive to-11

bacco cessation treatment, including counseling and 12

tobacco cessation therapies. 13

‘‘(2) FUNDING.—For the purpose of carrying 14

out this subsection, in addition to other amounts 15

available for such purpose, there is authorized to be 16

appropriated, and there is appropriated, out of funds 17

in the Treasury not otherwise appropriated, 18

$125,000,000 for each of fiscal years 2021 through 19

2025.’’. 20

(b) CONFORMING CHANGES.—Section 330 of the 21

Public Health Service Act (42 U.S.C. 254b) is amended— 22

(1) in subsection (c)(3)(B), by striking 23

‘‘(k)(3)(J)’’ and inserting ‘‘(l)(3)(J)’’; 24

(2) in subsection (e)(1)(B), by striking ‘‘(k)(3)’’ 25

each place it appears and inserting ‘‘(l)(3)’’; 26

41

•HR 2339 EH

(3) in subsection (l)(3)(H), as redesignated, by 1

striking ‘‘or (p)’’ and inserting ‘‘or (q)’’; 2

(4) in subsection (m), as redesignated— 3

(A) by striking ‘‘(k)(3)’’ and inserting 4

‘‘(l)(3)’’; and 5

(B) by striking ‘‘(m)’’ and inserting ‘‘(n)’’; 6

(5) in subsection (q), as redesignated, by strik-7

ing ‘‘(k)(3)(G)’’ and inserting ‘‘(l)(3)(G)’’; 8

(6) in subsection (s)(2)(A), as redesignated— 9

(A) by striking ‘‘(k)(3)’’ and inserting 10

‘‘(l)(3)’’; and 11

(B) by striking ‘‘(k)(3)(H)’’ and inserting 12

‘‘(l)(3)(H)’’; and 13

(7) in subsection (s)(3)(I), as redesignated, by 14

striking ‘‘(q)(4)’’ and inserting ‘‘(r)(4)’’. 15

(c) TECHNICAL CORRECTIONS.— 16

(1) Section 330(h)(5)(B) of the Public Health 17

Service Act (42 U.S.C. 254b(h)(5)(B)) is amended 18

by striking ‘‘substance abuse’’ each place it appears 19

and inserting ‘‘substance use disorder’’. 20

(2) Subclause (II) of subsection (l)(3)(E)(i), as 21

redesignated, of section 330 of the Public Health 22

Service Act (42 U.S.C. 254b) is amended by moving 23

the indentation 2 ems to the left. 24

42

•HR 2339 EH

SEC. 305. GRANTS FOR RESEARCH. 1

Part P of title III of the Public Health Service Act 2

(42 U.S.C. 280g et seq.) is amended by adding at the end 3

the following new section: 4

‘‘SEC. 399V–7. GRANTS FOR RESEARCH ON PREVENTION, 5

AND CESSATION, OF THE USE OF TOBACCO 6

PRODUCTS. 7

‘‘(a) IN GENERAL.—The Secretary shall award 8

grants to support— 9

‘‘(1) research to develop and improve effective 10

strategies for prevention, and cessation, of the use of 11

tobacco products, including— 12

‘‘(A) cessation of the use of flavored com-13

bustible cigarettes, including menthol-flavored 14

cigarettes; 15

‘‘(B) cessation of the use of e-cigarette 16

products; and 17

‘‘(C) prevention and cessation strategies 18

targeted toward youth; and 19

‘‘(2) research to aid in the development of safe 20

and effective tobacco cessation therapies, including 21

therapies appropriate for populations under the age 22

of 18. 23

‘‘(b) FUNDING.—To carry out this section, there is 24

authorized to be appropriated, and there is appropriated, 25

out of any funds in the Treasury not otherwise appro-26

43

•HR 2339 EH

priated, $75,000,000 for each of fiscal years 2021 through 1

2025.’’. 2

TITLE IV—NICOTINE OR VAPING 3

ACCESS PROTECTION AND 4

ENFORCEMENT 5

SEC. 401. INCREASING CIVIL PENALTIES APPLICABLE TO 6

CERTAIN VIOLATIONS OF RESTRICTIONS ON 7

SALE AND DISTRIBUTION OF TOBACCO PROD-8

UCTS. 9

(a) PENALTIES.—Subparagraph (A) of section 10

103(q)(2) of the Family Smoking Prevention and Tobacco 11

Control Act (21 U.S.C. 333 note) is amended to read as 12

follows: 13

‘‘(A) IN GENERAL.—The amount of the 14

civil penalty to be applied for violations of re-15

strictions promulgated under section 906(d), as 16

described in paragraph (1), shall be as follows: 17

‘‘(i) With respect to a retailer with an 18

approved training program, the amount of 19

the civil penalty shall not exceed— 20

‘‘(I) in the case of the first viola-21

tion, $0, together with the issuance of 22

a warning letter to the retailer; 23

44

•HR 2339 EH

‘‘(II) in the case of a second vio-1

lation within a 12-month period, 2

$500; 3

‘‘(III) in the case of a third viola-4

tion within a 24-month period, 5

$1,000; 6

‘‘(IV) in the case of a fourth vio-7

lation within a 24-month period, 8

$4,000; 9

‘‘(V) in the case of a fifth viola-10

tion within a 36-month period, 11

$10,000; and 12

‘‘(VI) in the case of a sixth or 13

subsequent violation within a 48- 14

month period, $20,000 as determined 15

by the Secretary on a case-by-case 16

basis. 17

‘‘(ii) With respect to a retailer that 18

does not have an approved training pro-19

gram, the amount of the civil penalty shall 20

not exceed— 21

‘‘(I) in the case of the first viola-22

tion, $500; 23

45

•HR 2339 EH

‘‘(II) in the case of a second vio-1

lation within a 12-month period, 2

$1,000; 3

‘‘(III) in the case of a third viola-4

tion within a 24-month period, 5

$2,000; 6

‘‘(IV) in the case of a fourth vio-7

lation within a 24-month period, 8

$4,000; 9

‘‘(V) in the case of a fifth viola-10

tion within a 36-month period, 11

$10,000; and 12

‘‘(VI) in the case of a sixth or 13

subsequent violation within a 48- 14

month period, $20,000 as determined 15

by the Secretary on a case-by-case 16

basis.’’. 17

(b) APPLICABILITY.—The amendment made by sub-18

section (a) applies with respect to a violation of a restric-19

tion promulgated under section 906(d)(1) of the Federal 20

Food, Drug, and Cosmetic Act (21 U.S.C. 387f(d)(1)), as 21

described in section 103(q)(1) of the Family Smoking Pre-22

vention and Tobacco Control Act (21 U.S.C. 333 note), 23

occurring on or after the day that is 6 months after the 24

date of enactment of this Act. The penalties specified in 25

46

•HR 2339 EH

section 103(q)(2)(A) of the Family Smoking Prevention 1

and Tobacco Control Act (21 U.S.C. 333 note), as in ef-2

fect on the day before the date of enactment of this Act, 3

shall continue to apply to violations occurring before the 4

day specified in the preceding sentence. 5

SEC. 402. STUDY AND REPORT ON E-CIGARETTES. 6

Not later than 5 years after the date of enactment 7

of this Act, the Comptroller General of the United States 8

shall— 9

(1) complete a study on— 10

(A) the relationship of e-cigarettes to to-11

bacco cessation; 12

(B) the perception of the harmful effects of 13

e-cigarettes; and 14

(C) the effects of secondhand exposure to 15

smoke from e-cigarettes; and 16

(2) submit to the Congress a report on the re-17

sults of such study, including recommendations 18

based on such results. 19

TITLE V—EXCISE TAX ON 20

NICOTINE USED IN VAPING, ETC. 21

SEC. 501. IMPOSITION OF TAX ON NICOTINE FOR USE IN 22

VAPING, ETC. 23

(a) IN GENERAL.—Section 5701 of the Internal Rev-24

enue Code of 1986 is amended by redesignating subsection 25

47

•HR 2339 EH

(h) as subsection (i) and by inserting after subsection (g) 1

the following new subsection: 2

‘‘(h) NICOTINE.—On taxable nicotine, manufactured 3

in or imported into the United States, there shall be im-4

posed a tax equal to the dollar amount specified in section 5

5701(b)(1) (or, if greater, $50.33) per 1,810 milligrams 6

of nicotine (and a proportionate tax at the like rate on 7

any fractional part thereof).’’. 8

(b) TAXABLE NICOTINE.—Section 5702 of such Code 9

is amended by adding at the end the following new sub-10

section: 11

‘‘(q) TAXABLE NICOTINE.— 12

‘‘(1) IN GENERAL.—Except as otherwise pro-13

vided in this subsection, the term ‘taxable nicotine’ 14

means any nicotine which has been extracted, con-15

centrated, or synthesized. 16

‘‘(2) EXCEPTION FOR PRODUCTS APPROVED BY 17

FOOD AND DRUG ADMINISTRATION.—Such term 18

shall not include any nicotine if the manufacturer or 19

importer thereof demonstrates to the satisfaction of 20

the Secretary of Health and Human Services that 21

such nicotine will be used in— 22

‘‘(A) a drug— 23

‘‘(i) that is approved under section 24

505 of the Federal Food, Drug, and Cos-25

48

•HR 2339 EH

metic Act or licensed under section 351 of 1

the Public Health Service Act; or 2

‘‘(ii) for which an investigational use 3

exemption has been authorized under sec-4

tion 505(i) of the Federal Food, Drug, and 5

Cosmetic Act or under section 351(a) of 6

the Public Health Service Act; or 7

‘‘(B) a combination product (as described 8

in section 503(g) of the Federal Food, Drug, 9

and Cosmetic Act), the constituent parts of 10

which were approved or cleared under section 11

505, 510(k), or 515 of such Act. 12

‘‘(3) COORDINATION WITH TAXATION OF OTHER 13

TOBACCO PRODUCTS.—Cigars, cigarettes, smokeless 14

tobacco, pipe tobacco, and roll-your-own tobacco 15

shall not be treated as containing taxable nicotine 16

solely because the nicotine naturally occurring in the 17

tobacco from which such product is manufactured 18

has been concentrated during the ordinary course of 19

manufacturing.’’. 20

(c) TAXABLE NICOTINE TREATED AS A TOBACCO 21

PRODUCT.—Section 5702(c) of such Code is amended by 22

striking ‘‘and roll-your-own tobacco’’ and inserting ‘‘roll- 23

your-own tobacco, and taxable nicotine’’. 24

49

•HR 2339 EH

(d) MANUFACTURER OF TAXABLE NICOTINE.—Sec-1

tion 5702 of such Code, as amended by subsection (b), 2

is further amended by adding at the end the following new 3

subsection: 4

‘‘(r) MANUFACTURER OF TAXABLE NICOTINE.— 5

‘‘(1) IN GENERAL.—Any person who extracts, 6

concentrates, or synthesizes nicotine shall be treated 7

as a manufacturer of taxable nicotine (and as manu-8

facturing such taxable nicotine). 9

‘‘(2) APPLICATION OF RULES RELATED TO 10

MANUFACTURERS OF TOBACCO PRODUCTS.—Any 11

reference to a manufacturer of tobacco products, or 12

to manufacturing tobacco products, shall be treated 13

as including a reference to a manufacturer of tax-14

able nicotine, or to manufacturing taxable nicotine, 15

respectively.’’. 16

(e) EFFECTIVE DATE.— 17

(1) IN GENERAL.—The amendments made by 18

this section shall apply to articles manufactured or 19

imported in calendar quarters beginning more than 20

90 days after the date of the enactment of this Act. 21

(2) TRANSITION RULE FOR PERMIT AND BOND 22

REQUIREMENTS.—A person which is lawfully en-23

gaged in business as a manufacturer or importer of 24

taxable nicotine (within the meaning of subchapter 25

50

•HR 2339 EH

A of chapter 52 of the Internal Revenue Code of 1

1986, as amended by this section) on the date of the 2

enactment of this Act, first becomes subject to the 3

requirements of subchapter B of chapter 52 of such 4

Code by reason of the amendments made by this 5

section, and submits an application under such sub-6

chapter B to engage in such business not later than 7

90 days after the date of the enactment of this Act, 8

shall not be denied the right to carry on such busi-9

ness by reason of such requirements before final ac-10

tion on such application. 11

TITLE VI—FURTHER HEALTH 12

INVESTMENTS 13

SEC. 601. WAIVING MEDICARE COINSURANCE FOR 14

COLORECTAL CANCER SCREENING TESTS. 15

Section 1833(a) of the Social Security Act (42 U.S.C. 16

1395l(a)) is amended— 17

(1) in the second sentence, by striking ‘‘section 18

1834(0)’’ and inserting ‘‘section 1834(o)’’; 19

(2) by moving such second sentence 2 ems to 20

the left; and 21

(3) by inserting the following third sentence fol-22

lowing such second sentence: ‘‘For services furnished 23

on or after January 1, 2024, paragraph (1)(Y) shall 24

apply with respect to a colorectal cancer screening 25

51

•HR 2339 EH

test regardless of the code that is billed for the es-1

tablishment of a diagnosis as a result of the test, or 2

for the removal of tissue or other matter or other 3

procedure that is furnished in connection with, as a 4

result of, and in the same clinical encounter as the 5

screening test.’’. 6

SEC. 602. SAFE HARBOR FOR HIGH DEDUCTIBLE HEALTH 7

PLANS WITHOUT DEDUCTIBLE FOR CERTAIN 8

INHALERS. 9

(a) IN GENERAL.—Section 223(c)(2)(C) of the Inter-10

nal Revenue Code of 1986 is amended— 11

(1) by striking ‘‘for preventive care’’ and insert-12

ing ‘‘for one or more of the following: 13

‘‘(i) Preventive care’’, and 14

(2) by adding at the end the following new 15

clause: 16

‘‘(ii) Inhalers or nebulizers for treat-17

ment of any chronic lung disease (and any 18

medicine or drug which is delivered 19

through such inhaler or nebulizer for treat-20

ment of such disease).’’. 21

(b) CONFORMING AMENDMENT.—The heading for 22

section 223(c)(2)(C) of such Code is amended by striking 23

‘‘PREVENTIVE CARE DEDUCTIBLE’’ and inserting ‘‘CER-24

TAIN DEDUCTIBLES’’. 25

52

•HR 2339 EH

(c) EFFECTIVE DATE.—The amendments made by 1

this section shall apply to months beginning after the date 2

of the enactment of this Act. 3

Passed the House of Representatives February 28,

2020.

Attest:

Clerk.

11

6T

HC

ON

GR

ES

S

2D

SE

SS

ION

H

. R. 2339

AN

AC

T

To am

end th

e F

edera

l F

ood,

Dru

g,

an

d C

osm

etic A

ct with

respect to

the sa

le an

d m

ark

eting o

f to-

bacco

pro

du

cts, an

d fo

r oth

er pu

rposes.